TY - JOUR T1 - A Quality by Design Approach to Microbial Retention Validation JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2022.012739 SP - pdajpst.2022.012739 AU - Annie Leahy AU - Jennifer Juneau AU - Kathleen Souza AU - Corinne Miller AU - Nhung Nguyen AU - Herb Lutz AU - Parag Kolhe Y1 - 2022/01/01 UR - http://journal.pda.org/content/early/2022/07/15/pdajpst.2022.012739.abstract N2 - Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to sterilizing filtration supports a paradigm that would obviate the need for product-specific testing for early-stage products that do not have the quantity of material required to perform such testing easily and efficiently. Process and product parameters were varied to determine their effect on microbial retention to define a design space. To minimize the burden of filter validation retention studies for early stage (Phase 1) manufacturing, it is recommended that manufacturers perform a risk assessment to confirm their product and process conditions are within the established design space. For later stage product development prior to marketing authorization, product specific filter validation testing is expected. ER -